drugset / Trial / NCT04836195
Study of PCLX-001 in R/R Advanced Solid Malignancies and B-cell Lymphoma
RandomizedSequentialOpen-labelTreatment
Summary
This is a phase I dose-escalation study of oral PCLX-001, conducted in a multicenter, non-randomized, open-label, non-controlled design. The study is comprised of two parts: Part A (single-agent dose escalation) and Part B (single-agent expansion cohorts).
Timeline
- Start
- 2021-09-14
- Primary completion
- 2024-10-28
- Completion
- 2024-10-28
Publications
- Background Beauchamp E, Yap MC, Iyer A, Perinpanayagam MA, Gamma JM, Vincent KM, Lakshmanan M, Raju A, Tergaonkar V, Tan SY, Lim ST, Dong WF, Postovit LM, Read KD, Gray DW, Wyatt PG, Mackey JR, Berthiaume LG. Targeting N-myristoylation for therapy of B-cell lymphomas. Nat Commun. 2020 Oct 22;11(1):5348. doi: 10.1038/s41467-020-18998-1.
- Results Sangha R, Jamal R, Spratlin J, Kuruvilla J, Sehn LH, Beauchamp E, Weickert M, Berthiaume LG, Mackey JR. A first-in-human phase I trial of daily oral zelenirstat, a N-myristoyltransferase inhibitor, in patients with advanced solid tumors and relapsed/refractory B-cell lymphomas. Invest New Drugs. 2024 Aug;42(4):386-393. doi: 10.1007/s10637-024-01448-w. Epub 2024 Jun 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zelenirstat | Small molecule | 20 mg | Oral |
| Subject | zelenirstat | Small molecule | 40 mg | Oral |
| Subject | zelenirstat | Small molecule | 70 mg | Oral |
| Subject | zelenirstat | Small molecule | 100 mg | Oral |
| Subject | zelenirstat | Small molecule | 140 mg | Oral |
| Subject | zelenirstat | Small molecule | 210 mg | Oral |
| Subject | zelenirstat | Small molecule | 280 mg | Oral |